Patent Application
20220110715
This application claims priority to European patent application No. 20200962.7 filed on Oct. 9, 2020, which disclosure is incorporated herein by reference in its entirety.
The invention relates to a film tensioning element.
Film tensioning elements have been successfully in use for more than ten years, under the name OPTRAGATE®, for allowing free access to a patient's mouth during dental operations in the patient's oral cavity. It consists of a vestibular ring and a lip ring between which a film extends. In this element, the film is mounted displaceably with respect to the two rings and is resilient. To avoid allergy-related damage, it is formed latex-free.
US 20040097795 and US 20080153058 are directed to lip and cheek expanders and are hereby incorporated by reference in their entirety. Further, EP 3 666 221 A1, US 20200188060A1 and US 20210177251A1, which published US patent applications are hereby incorporated by reference, disclose a film tensioning element in which an elastic band is integrated into the film. The elastic band doubles up the film, in such a way that this combination of the film and the tensioning element has a greater tensile force there than the film otherwise would have alone. The radially inwardly directed tension on the film from the elastic band results in a constriction, both of the elastic band and of the film, in such a way that the radially outwardly directed pressure on the lips is reduced.
This embodiment has the drawback, by comparison with the other embodiments disclosed in said document, that it is comparatively complex and expensive to manufacture. In addition, the turned-over elastic band causes a permanent tension within the film and the band.
During the storage period, this constriction effect can slacken and lose its effect.
It would be possible to integrate the elastic band into the film, for example by peripheral sealing. However, the radially inwardly directed tensile force leads to fold formation, and as a result, one of the other embodiments described in said patent publication has become established instead of this solution using the doubled-up elastic band.
By contrast, the object of the invention is to provide a film tensioning element in accordance with claim 1 which improves the comfort of wearing the film tensioning element.
This object is achieved according to the independent claims. Advantageous embodiments may be drawn from the dependent claims.
Surprisingly, the combination of the measures according to the invention, in other words both providing the film itself with a radially inwardly extending constriction and also manufacturing the film without tension, in other words with the constriction arising in the film by itself without tension, without a tensile force having to be implemented using an elastic band which thickens the film, leads to the advantage that no folds occur, but yet no radially outwardly directed pressure is exerted on the lips.
Surprisingly, a further advantage also occurred, specifically that it is possible to save on material. The film may have a constant material thickness over the progression thereof, and this results in saving on material, both by comparison with the presented embodiment in FIG. 6 of EP 3 666 221 A1, US 20200188060A1 and US 20210177251A1, and even with respect to the conventional OPTRAGATE® film tensioning solution where the film extends between the vestibular ring and the lip ring in a frustum shape, if the film tensioning element is held on one of the rings.
The film tensioning element is a mass-produced product. Considered on an industrial scale, this material saving affects the weight and allows a considerable reduction in manufacturing costs.
The film extends between the lip ring and vestibular ring in a ring or hose shape in a manner known per se.
An advantageous configuration provides that the constriction is merely provided over part of the periphery. As is known, a half-open mouth has a substantially oval shape. This shape can now be taken into account in that the constriction is central, in other words extends for example over an upper and a lower quarter-circle when the film tensioning element is inserted into the mouth, and no constriction is provided in the region of the two outer quarter-circles. As a result, a particularly scanning-friendly configuration is implemented, which also makes it possible to scan side regions of the patient's mouth.
The material thickness of the film is preferably constant over the entire film.
The material thickness may for example be between 0.1 mm and 1 mm, and is preferably between 0.3 and 0.4 mm. The material thickness of the film of a film tensioning element provided to children is preferably slightly less, for example 0.2 or 0.3 mm. This reduces the tensile force of the film, and surprisingly no folds occur either, or at most very slight folds, in a smaller configuration of this type of the film tensioning element according to the invention.
According to the invention, it is also particularly favorable that the point at which the constriction is implemented can be adapted to requirements within wide ranges. In a preferred configuration, the constriction extends more closely adjacent to the vestibular ring than to the lip ring. As a result, it is possible to configure the vestibular ring with a comparatively low diameter, and this in turn leads to a savings on material. This reduction in diameter may for example be between 10 and 20 percent.
In another configuration, the constriction is provided close to the lip ring.
Because the film is free of overlays and/or inlays, the tensile force when loaded is constant over the entire extension thereof. This applies both in the longitudinal direction, in other words the direction between the vestibular ring and the lip ring, and in the tangential direction, in other words peripherally.
This also results in introduced tensions being absorbed uniformly over the entire extension. As a result, the film is loaded uniformly by the introduced radially inwardly acting tension. The load per unit area is thus much less than when an additional elastic band is intensively connected to the film.
The constant thickness which is provided in an advantageous configuration thus has the particular advantage that the tear resistance is increased by comparison with the described previously known solution. This measure again makes it possible to reduce the production costs, since the solution using the thickening is less tear-resistant than the solution according to the invention, in spite of having the same size for the same material weight.
Although a fluctuation of for example 10 percent in the material thickness does not affect the weight as regards to the stability of the film, a significant thickening, formed as an elastic band and extending over for example a third of the length of the film in the longitudinal direction, does weaken the remaining part of the film; the stretching of the film occurs almost exclusively in the remaining two thirds of the film, at least if the material thickness of the thickening is for example three times the film thickness elsewhere, for example as a result of the integrated elastic inlay.
Thus, in spite of a higher total weight, the tear resistance of the film tensioning element of the previously known solution is only approximately two thirds of the tear resistance of the film tensioning element according to the invention.
The depth of the constriction can be adapted to requirements within wide ranges. Thus, the depth may also equally well have an oval progression. Thus, in a first configuration it is largest in the mouth center region and smallest in the side region.
In a second configuration, these relationships are reversed, the depth being largest in the side region and smallest in the mouth region.
It is also possible to provide the depth of the constriction to be variable, as considered in a tangential direction, from the outset, with soft transitions between the different depths, and, when the film tensioning element is used on and in the patient's mouth, to rotate the film tensioning element in such a way that the comfort of wearing is thus optimal. As a result of the different shapes of patients' mouths, optimized patient-specific adaptation can thus be achieved using this measure.
The film tensioning element may be manufactured in any desired manner. For example, the film may be produced by an injection-molding process, the injection mold predetermining the configuration of the subsequent shape of the film in the limp state. The rings may be inlaid in the injection mold and be molded around.
A dipping process or blow-molding process is also possible instead.
It is also possible to provide the film with variable thickness as considered about the periphery thereof in particular cases, the differences, in this case too, preferably not being more than 20 percent, and soft transitions again being provided between the different thicknesses of the films.
For the above-described particularly good tear resistance of the film, it is important that the film has a constant thickness as considered in the longitudinal direction. The greatest introduced tension comes from a patient's lip, which tensions the film in the longitudinal direction.
If the thickness progression is to be selected to be variable in the longitudinal direction, it is preferred to limit the fluctuation and the differences to ±20 percent in this case too.
In a further advantageous configuration, a net structure of the film is provided using the finite element method (FEM). This is particularly preferably implemented in such a way that the meshes of the net have a lower film wall thickness than the lattice of the net. This does not impair the sealing by the film according to the invention, but the strength in relation to the weight used is further improved.
This applies in particular if the net structure is determined while taking into account a calculation by the finite element method.
The radial depth of the constriction can be adapted to the requirements within wide ranges. It is dimensioned as a reduction in diameter with respect to a standard OPTRAGATE® film tensioning element, in other words the prior art film tensioning element.
Said element extends in a frustum shape, at least when it is held suspended on the lip ring or vestibular ring without an additional tension and/or tensile forces being introduced.
When the film tensioning element according to the invention is held suspended on the lip ring or vestibular ring without an additional tension and/or tensile forces being introduced, it has a shape having a radially inwardly extending constriction.
The depth of the constriction may be 5 to 35% of the diameter of the lip ring, in particular approximately 15%.
According to the invention, it is particularly favorable for the film to extend in one piece. The single-piece nature applies in all directions, in other words in a direction parallel to the axis between the vestibular ring and lip ring, in a tangential direction, and also in the thickness direction thereof.
This means that the film is likewise a single-piece between the radially inwardly directed inner face thereof and the radially outwardly directed outer face thereof, and has no overlays or supports and/or inlays or inserts.
As a result of the single-piece nature, a tension gradient within the film is prevented or reduced. This increases the tear resistance, and tension peaks do not occur anywhere, but instead the introduced tensions are made uniform.
The constriction according to the invention may also be considered as a concavity or inward curvature. What is important is the change in diameter as considered along the axis. Starting from the lip ring, the diameter initially decreases, specifically without points of discontinuity and initially decreasing monotonically.
In the region of the deepest constriction, the diameter of the film is lowest. There is an inflection point here, but again no point of discontinuity. Starting from this inflection point, the diameter of the film increases again until the vestibular ring.
Even though other curve shapes of the film are possible in this regard, implementation of a catenary or a rounded-tip V is preferred.
It is preferred that a film tensioning element for performing dental operations in a patient's oral cavity is provided having a vestibular ring and a lip ring between which vestibular ring and lip ring, and optionally beyond which, a film extends, the film being held tensioned by the rings, the film and the rings being resiliently deformable, wherein the film has a radially inwardly extending constriction, at least in a region between the lip ring and vestibular ring, the film at least in said region extending without tension and in a single piece between an inner face and an outer face thereof free of any supports and/or inserts.
It is preferred that the film has, in the region between the lip ring and vestibular ring, a constant thickness within a standard of deviation of ±20% of the constant thickness, and/or wherein the film has a lower diameter at the constriction than at the rings.
It is preferred that the region of the constriction is ring-shaped (360 degrees) or part-ring-shaped or partially ring-shaped (less than 360 degrees).
It is preferred that the region of the constriction extends over less than 99% and more than 30% of a distance between the vestibular ring and the lip ring. Depending on how the film tensioning element is manufactured, it has a “broader” or “less broad” constriction—in the side view. “Broad” would be 99%, reaching from the vestibular ring to the lip ring. If the constriction extends only over a third of the distance between the rings it would be “less broad”.
It is preferred that the depth of the constriction, as considered radially inwards, is variable over the periphery of the film.
It is preferred that the depth of the constriction is greater at a point intended for the cheeks. “Greater” can mean that it is greater compared to the tangential remainder of the depth. The depth may have a range of for example, 1% to 30%, preferably between 10% and 20%.
It is preferred that the depth of the constriction is greater at a point intended for the mouth center at and around the sagittal plane.
It is preferred that the constriction shapes the film radially inwards without tension and/or a point of the greatest depth of the constriction is in the center between the rings or shifted towards the lip ring with respect to the center, the center being half way from the lip and vestibular rings.
It is preferred that the film, as considered in a section through the lip ring and vestibular ring, extends in a catenary manner in the limp state, or wherein the film, as considered in a longitudinal section parallel to the axis of the film tensioning element, extends substantially in a manner of a V or is V-shaped.
It is preferred that the film is manufactured by an injection-molding process, a pressing process, a dipping process or a blow-molding process.
It is preferred that the film has different thicknesses about the periphery of the film tensioning element, between the lip ring and vestibular ring.
It is preferred that the constriction of the film has a maximum depth of at least 5 times or at least 10 times or at least 15 times the maximum thickness of the film.
It is preferred that the constriction the film has different wall thicknesses in the periphery.
It is preferred that the film has a net structure, which is established while taking into account an FEM calculation. It is preferred that the meshes of the net have a lower wall thickness than the lattice of the net.
Further advantages, details and features of the invention may be drawn from the following description of a plurality of embodiments with reference to the accompanying drawings, in which:
In the embodiment shown, in a manner likewise known per se, the vestibular ring 16 has a somewhat smaller diameter than the lip ring 14.
According to the invention, the film 12 is constricted between the two rings 14 and 16.
In the embodiment shown, this constriction 18 is formed symmetrically, in such a way that the deepest point of the constriction 18 is in the center between the lip ring 14 and vestibular ring 16.
In the embodiment shown, the constriction 18 is formed ring-shaped peripherally, in such a way that at all points of the ring-shaped film tensioning element 10 the smallest or lowest diameter of the film tensioning element is in the region of the constriction 18.
In the embodiment shown in
The position and shape shown in
The film tensioning element 10 may be manufactured for example in an injection-molding process. Preferably, in this case the lip ring 14 and vestibular ring 16 are laid in the injection mold and are molded around with the material of the film 12. In a manner known per se, the material of the film 12 is resilient and comparatively soft, while the rings 14 and 16 consist of a comparatively harder plastics material.
The injection mold is formed in such a way that, starting from the rings 14 and 16, the thickness of the film 12 tapers continuously and in a soft transition. The region of the taper can be kept small, for example approximately corresponding to the thickness of each ring 14 or 16. This solution makes possible, with low use of material, a construction of the film 12 which is optimized in terms of load capacity.
In the depiction of
The load capacity of the film tensioning element 10 according to the invention is at least equally good. However, the material use is slightly less, for example by 10 to 20%, depending on the depth of the constriction 18. As a result of the reduction in diameter in the region of the constriction 18, less material is required.
By comparison with the likewise known film tensioning element 10 according to the above-mentioned patent publication, which has a doubled-up elastic band, the material use is much lower, since no elastic band is used, but rather the film 12 has a constant, uniform thickness over the extension thereof between the rings 14 and 16, again with the exception of the aforementioned taper 24.
Surprisingly, the centrally provided constriction 18, which is preferably V-shaped, results in an extremely wearer-friendly adaptation to the lips of the patient, which reduces the lip pressure and thus increases acceptance.
Surprisingly, by way of the central radius 22, a considerable improvement can thus be achieved by comparison with an asymmetrically arranged elastic band.
A major advantage of the invention is that, by way of appropriate tool configuration, for example the injection mold shape, the constriction may be positioned centrally, but also equally well non-centrally, and thus for example closer in part to one of the two rings or optionally with different V depths. It may also, as a whole, only be present in part of the tensioning element.
Since the thickness of the film 12 is uniform or substantially uniform over the entire extension thereof between the two rings 14 and 16, introduced tensions are distributed uniformly. The load capacity is thus likewise surprisingly improved according to the invention by comparison with the elastic band solution, in spite of the higher material use of said solution.
For clarity, it should be noted that the lines additionally shown in
From
In the embodiment shown, the thickness of the film 12 is constant between the rings 14 and 16, optionally with the exception of the associated tapers 24 and 26. In the embodiment of
By contrast, both in the embodiment of
In the embodiment shown in
It will be appreciated that any other film thicknesses adapted to the size and shape of the film tensioning elements 10 are also possible, for example between 0.1 mm for small film tensioning elements for children's mouths and 1 mm in the event of a heavy load or in applications on larger mouths, in which film tensioning elements 10 of this type may likewise be used.
As can be seen from
A modified embodiment of the film tensioning element 10 according to the invention can be seen from
In
In the embodiment of
Even though in this case the deepest point of the constriction 18 extends in the center between the rings 14 and 16 in each case, it will be appreciated that a slight deviation thereof either towards the vestibular ring 16 or towards the lip ring 14 is possible without departing from the scope of the invention.
In a modified embodiment, it is provided that the constriction 18 is larger at the point intended for the cheeks.
In an alternative embodiment, it is provided that the depth 34 of the constriction 18 is greater at the point intended for the mouth center. It is thus greatest in the region of the patient's sagittal plane.
Although in this case the constriction 18 is provided with a constant depth 34 over the entire ring-shaped progression of the film 12, in other words in the circumferential direction or tangential direction, in a further embodiment it is provided that the depth 34 of the constriction 18 is varied over the ring shape. The constriction 18 may also merely extend in a partial ring shape.
The region of the constriction 18 also need not extend over the entire distance between the vestibular ring 16 and lip ring 14; it is also possible to provide the constriction 18 for example centrally with a smaller extension parallel to the axis.
According to the invention, the depth 34 can be adapted to the requirements within wide ranges, for example by appropriate configuration of the injection mold. The depth 34 may, according to the invention, preferably be between 8% and 80% of the distance between the lip ring 14 and vestibular ring 16.
On the other hand, in the embodiment of
This considerable decrease in diameter saves a significant amount of film material.
In the embodiments shown in
As explained previously with reference to
As an alternative to the injection molding process, it is also possible to manufacture the film tensioning element 10 according to the invention by a pressing process, a dipping process or a glass shaping process.
If the film according to the invention is manufactured from silicone materials, the rings may be laid in the press mold beforehand and encapsulated.
The film 12 may also have different thicknesses as considered over the periphery.
These different thicknesses correspond to the different depths 34 of the constriction 18.
In a direction parallel to the axis 40, however, the thickness of the film 12 is preferably always a constant thickness between the lip ring 14 and vestibular ring 16, optionally with the exception of tapers 24 and 26.
In a further modified configuration, it is provided that the film 12 has a net structure. This is preferably calculated by the finite element method, and serves to optimize the material saving further. The thickness of the film 12 is then for example merely 0.1 mm in the region of the meshes of the net and 0.3 mm in the region of the lattice of the net.
In the embodiment of
In this embodiment, tapers 26 and 24 may be provided in accordance with
The term “about” and “substantially” is intended to include the degree of error or uncertainty associated with measurement of the particular quantity or shape as one of ordinary skill in the art would understand. For example, but not limited to, “about” and “substantially” can include a range of ±0.01% to 15%, or 2% to 10%, or 5% to 25% of a given shape or value.
As a result of the curved shape, the vestibular ring 16 can more easily be introduced into the patient's mouth, and also more easily takes on the desired oval shape, which corresponds to the patient's mouth.
Although the present invention has been described in connection with preferred embodiments thereof, it will be appreciated by those skilled in the art that additions, deletions, modifications, and substitutions not specifically described may be made without department from the spirit and scope of the invention as defined in the appended claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 20200962.7 | Oct 2020 | EP | regional |
